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2013-05-02
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Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program
Notices
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United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
78 FR 25749
https://www.govinfo.gov/app/details/FR-2013-05-02/2013-10379
2013-10379
fr02my13-60
4160-01-P
Docket No. FDA-2013-N-0294
https://www.govinfo.gov/app/details/FR-2013-05-02/2013-10379
https://www.govinfo.gov/content/pkg/FR-2013-05-02/html/2013-10379.htm
https://www.govinfo.gov/content/pkg/FR-2013-05-02/pdf/2013-10379.pdf
1 p.
25749
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78 FR 25749
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program; Federal Register Vol. 78, Issue
NOTICE
2013-10379
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-N-0294
4160-01-P
2013-10379
Notice.
The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
The XML-enabled Adobe PDF form, Form FDA 3331--Automated, will be available for piloting between May 1, 2013, and January 1, 2014.
Mark Browning, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5342.
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports:
Automated Form Pilot Program
,
CDER-FAR-XML@fda.hhs.gov
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm347604.htm
http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 85
Office of the Federal Register, National Archives and Records Administration
2013-05-02
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230 p.
Table of Contents:
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GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2013-05-02
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https://www.govinfo.gov/app/details/FR-2013-05-02
https://www.govinfo.gov/content/pkg/FR-2013-05-02/pdf/FR-2013-05-02.pdf
https://www.govinfo.gov/content/pkg/FR-2013-05-02/xml/FR-2013-05-02.xml
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